The following data is part of a premarket notification filed by Etkon International Gmbh with the FDA for Zerion Alpha, ; Zerion Beta.
| Device ID | K061804 |
| 510k Number | K061804 |
| Device Name: | ZERION ALPHA, ; ZERION BETA |
| Classification | Powder, Porcelain |
| Applicant | ETKON INTERNATIONAL GMBH LOCHHAMER SCHLAG 6 Grafelfing, Bavaria, DE 82166 |
| Contact | Matthias Zitzmann |
| Correspondent | Matthias Zitzmann ETKON INTERNATIONAL GMBH LOCHHAMER SCHLAG 6 Grafelfing, Bavaria, DE 82166 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-27 |
| Decision Date | 2006-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031701299 | K061804 | 000 |
| 07630031701312 | K061804 | 000 |
| 07630031701329 | K061804 | 000 |
| 07630031701336 | K061804 | 000 |
| 07630031701343 | K061804 | 000 |
| 07630031701350 | K061804 | 000 |
| 07630031701367 | K061804 | 000 |
| 07630031701374 | K061804 | 000 |
| 07630031701381 | K061804 | 000 |
| 07630031701398 | K061804 | 000 |
| 07630031701404 | K061804 | 000 |
| 07630031701411 | K061804 | 000 |
| 07630031701428 | K061804 | 000 |
| 07630031701435 | K061804 | 000 |
| 07630031701442 | K061804 | 000 |
| 07630031701282 | K061804 | 000 |
| 07630031701305 | K061804 | 000 |